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Legal challenges to FDA regulations -- specifically the agency's ban on off-label promotion -- are emerging in the wake of the U.S. Supreme Court decision in Sorrell v. IMS Health. Read more about the recent legal actions, and how they may redefine off-label promotional activities, in an article posted on the Coalition for Healthcare Communication website, courtesy of The RPM Report.

Related Summaries

The FDA is considering bringing a misdemeanor charge against executives of pharmaceutical companies that promote treatments for off-label use, said Eric Blumberg, the agency's deputy chief for litigation. "Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion," Blumberg said.

Novartis Pharmaceuticals pleaded guilty to a misdemeanor charge and agreed to pay $185 million for a criminal fine and forfeiture regarding off-label marketing of epilepsy drug Trileptal. The company will also pay a civil penalty of $237.5 million in a settlement agreement on the off-label promotion and for charges of paying physicians to prescribe Trileptal and five other treatments.

Novartis Pharmaceuticals pleaded guilty to a misdemeanor charge and agreed to pay $185 million for a criminal fine and forfeiture regarding off-label marketing of epilepsy drug Trileptal. The company will also pay a civil penalty of $237.5 million in a settlement agreement on the off-label promotion and for charges of paying physicians to prescribe Trileptal and five other treatments.

Drugmakers can be convicted of a crime for influencing medical experts to employ their products for off-label uses, even when there's good evidence of the benefits, writes Scott Gottlieb, a fellow at the American Enterprise Institute and former FDA deputy commissioner. Eli Lilly and Co. was convicted for promoting Evista for off-label use, but its "crime" could be seen as public service, Gottlieb says.

Robert Temple, who heads up the medical policy office at the FDA's Center for Drug Evaluation & Research, emphasizes that off-label promotion rules for drug companies are clear in their prohibition of the practice, but that some off-label use, as prescribed by doctors, can provide reasonable and appropriate treatments and can offer treatment options when no others are available for certain conditions.